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FDA 510(k)

PENCURE, MODEL VL-7

K-Number: K063529 · 2007-01-05

ApplicantJ. Morita USA, Inc.
Decision Date2007-01-05
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PENCURE, MODEL VL-7 is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2007-01-05 under 510(k) number K063529. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENCURE, MODEL VL-7?

PENCURE, MODEL VL-7 is a medical device that received FDA 510(k) clearance on 2007-01-05. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K063529.

When did PENCURE, MODEL VL-7 receive FDA 510(k) clearance?

PENCURE, MODEL VL-7 received FDA 510(k) clearance on 2007-01-05, under 510(k) number K063529.

Who is the listed applicant for PENCURE, MODEL VL-7?

The FDA 510(k) record lists J. Morita USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENCURE, MODEL VL-7?

The FDA product code for PENCURE, MODEL VL-7 is EBZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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